(164 days)
Not Found
No
The device description and performance studies focus on standard chemical and immunochemical assay technologies (photometry, ion selective electrodes, dye-binding) and traditional statistical analysis of performance data (linearity, precision, method comparison). There is no mention of AI, ML, or related concepts.
No.
The device is an in vitro diagnostic (IVD) test that performs quantitative measurements of analytes in human specimens. It aids in diagnosis and treatment but is not a therapeutic device itself.
Yes
The Trinidad CH System is designed to perform in vitro diagnostic tests on clinical specimens, and the measurements it provides are explicitly stated to be used in the diagnosis and treatment of various diseases and conditions (e.g., aldosteronism, diabetes insipidus, electrolyte imbalance, cystic fibrosis, diabetic acidosis, liver/kidney diseases).
No
The device description explicitly states it is a "floor model, fully automated, microprocessor-controlled, integrated instrument system" that uses "photometric and integrated ion selective multisensor detection technologies." This indicates it is a physical hardware device, not software only.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement in Intended Use: The very first sentence of the "Intended Use / Indications for Use" section clearly states: "The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens."
- Performance of Tests on Clinical Specimens: The device is designed to perform tests on "human serum, plasma and urine," which are clinical specimens.
- Diagnostic and Treatment Purposes: The intended use describes how the measurements obtained by the device are used in the "diagnosis and treatment" of various diseases and conditions (e.g., aldosteronism, diabetes insipidus, electrolyte imbalance, cystic fibrosis, diabetic acidosis). This is a core function of IVD devices.
- Use of Reagents and Calibrators: The description mentions the use of "prepackaged reagent packs," "TD-LYTE Integrated Multisensor," "TD-LYTE IMT Standard A," "TD-LYTE IMT Standard B + Salt Bridge," "Albumin BCP Reagent," and "Albumin BCP calibrator." These are all components typically used in in vitro diagnostic assays.
- Calibration and Measurement of Analytes: The device performs quantitative measurements of analytes (sodium, potassium, chloride, albumin) in the specimens, which is a characteristic of IVD devices used for clinical analysis.
- Performance Studies: The document details various performance studies (Detection Limit, Limit of Quantitation, Linearity, Precision, Interferences, Dilution Recovery, Method Comparison) which are standard evaluations for IVD devices to demonstrate their analytical performance.
- Predicate Devices: The listed predicate devices (ADVIA 1800 Chemistry, ADVIA Sodium, Potassium, Chloride, Albumin assays and calibrators) are also IVD devices, indicating the regulatory classification of similar systems.
All of these points strongly support the classification of the Trinidad CH System as an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The TD-L YTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.
The Albumin BCP Reagent (Alb P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.
Product codes (comma separated list FDA assigned to the subject device)
JGS, CEM, CGZ, CJW, JIX, JIT, JJE
Device Description
The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).
Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.
A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.
The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.
The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.
The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.
Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.
Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.
The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.
The target concentration of the albumin is 4.3 g/dL.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Assay performance comparison results for the representative Trinidad CH system assays and their predicate assays were obtained by processing the appropriate body fluids. Summary statistics for each representative assay are provided. These data demonstrate substantial equivalency of the representative assays processed on the Trinidad CH system versus their predicate assays. The following data represent typical assay performance.
Detection Limit
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.
- TD-LYTE Integrated Multisensor (Na, K, Cl) Limit of Detection Results with Serum
- Na: LoB: 10.2 mmol/L, LoD: 11.9 mmol/L
- K: LoB: 0.244 mmol/L, LoD: 0.279 mmol/L
- Cl: LoB: 2.23 mmol/L, LoD: 4.43 mmol/L
- TD-LYTE Integrated Multisensor (Na, K, Cl) Trinidad CH Limit of Detection Results with Urine
- Na: LoB: 4.72 mmol/L, LoD: 5.30 mmol/L
- K: LoB: 0.00 mmol/L, LoD: 0.079 mmol/L
- Cl: LoB: 4.86 mmol/L, LoD: 5.47 mmol/L
- Trinidad CH Albumin_P Limit of Detection Results
- LoB: 0.1 g/dL, LoD: 0.2 g/dL
Limit of Quantitation (LoQ)
Evaluated as described in CLSI Document EP17-A2.
- Na:
- Serum/Plasma: 40.4 mmol/L (Total Error: 4.8%)
- Urine: 5.35 mmol/L (Total Error: 1.78 mmol/L or 27%)
- K:
- Serum/Plasma: 0.792 mmol/L (Total Error: 16.3%)
- Urine: 1.03 mmol/L (Total Error: 22%)
- Cl:
- Serum/Plasma: 38.3 mmol/L (Total Error: 10.3%)
- Urine: 15.8 mmol/L (Total Error: 16%)
- Albumin: 0.4 g/dL (Inter-assay precision
§ 862.1665 Sodium test system.
(a)
Identification. A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, with flowing lines representing movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
SIEMENS HEALTHCARE DIAGNOSTICS, INC. LAURA DUGGAN, REGULATORY TECHNICAL SPECIALIST 500 GBC DRIVE, M/S 514 PO BOX 6101 NEWARK DE 19714-6101
December 11, 2015
Re: K151767 Trade/Device Name: Trinidad CH System; TD-LYTE Integrated Multisensor (Na, K, Cl); TD-LYTE IMT Standard A; TD-LYTE IMT Standard B + Salt Bridge; Trinidad CH Albumin BCP Reagent (Alb P): Trinidad CH Albumin BCP Calibrator. Regulation Number: 21 CFR 862.1665 Regulation Name: Sodium test system Regulatory Class: II Product Code: JGS, CEM, CGZ, CJW, JIX, JIT, JJE Dated: November 9, 2015 Received: November 10, 2015
Dear Laura Duggan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
1
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Katherine Serrano -S
For : Courtney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151767
Device Name
Trinidad CH System; TD-LYTE Integrated Multisensor (Na, K, Cl); TD-LYTE IMT Standard B + Salt Bridge; Trinidad CH Albumin BCP Reagent (Alb P); Trinidad CH Albumin BCP Calibrator
Indications for Use (Describe)
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
The TD-LYTE Integrated Multisensor (Na, K, Cl) is intended for in the quantitative determination of sodium, potassium and chloride (Na, K, Cl) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
The TD-L YTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.
The Albumin BCP Reagent (Alb) P) is intended for in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
The Albumin BCP calibrator is for in vitro diagnostic use in the Trinidad CH Albumin BCP Assay (Alb P) on the Trinidad CH System.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------------------------------------------------------ | ----------------------------------------------------------------------------------------------- |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
| Department of Health and Human Services |
|---|
| Food and Drug Administration |
| Office of Chief Information Officer |
| Paperwork Reduction Act (PRA) Staff |
| PRAStaff@fda.hhs.gov |
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
ASSIGNED 510(K) NUMBER
The assigned 510(k) number is: K151767
APPLICANT AND DATE
Laura J. Duggan, Ph. D., RAC Siemens Healthcare Diagnostics Inc. 500 GBC Drive, M/S 514 Newark, DE 19714-6101 Email: laura.j.duggan@siemens.com Phone: 302-631-7654 Fax: 302-631-6299
December 7, 2015
MANUFACTURER
Siemens Healthcare Diagnostics Inc. 511 Benedict Ave Tarrytown, NY 10591 Registration Number: 2432235
PROPRIETARY NAME
Trinidad CH System TD-LYTE Integrated Multisensor (Na, K, CI) TD-LYTE IMT Standard A TD-LYTE IMT Standard B + Salt Bridge Trinidad CH Albumin BCP Reagent (Alb_P) Trinidad CH Albumin BCP Calibrator
4
Photometric Chemistry Analyzer Sodium Test System Chloride Test System Potassium Test System Albumin Test System Calibrator
REGULATORY INFORMATION
| Discrete photometric chemistry analyzer for clinical use (Class I) | |
|---|---|
| Classification Name: | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use |
| Regulation Section: | 21CFR862.2160 |
| Classification: | Class I |
| Product Code: | JJE |
| Panel: | Clinical Chemistry |
| Sodium, potassium, chloride and Albumin test systems and the associated calibrators (Class II) | |
| Classification Name: | Electrode, Ion Specific, Sodium |
| Regulation Section: | 21CFR862.1665, Sodium Test System |
| Classification: | Class II |
| Product Code: | JGS |
| Panel: | Clinical Chemistry |
| Classification Name: | Electrode, Ion Specific, Chloride |
| Regulation Section: | 21CFR862.1170, Chloride Test System |
| Classification: | Class II |
| Product Code: | CGZ |
| Panel: | Clinical Chemistry |
| Classification Name: | Electrode, Ion Specific, Potassium |
| Regulation Section: | 21CFR862.1600 |
| Classification: | Class II |
| Product Code: | CEM |
| Panel: | Clinical Chemistry |
| Classification Name: | Calibrator, Multi-Analyte Mixture |
| Regulation Section: | 21 CFR 862.1150 |
| Classification: | Class II |
| Product Code: | JIX |
| Panel: | Clinical Chemistry |
| Classification Name: | Bromocresol Purple Dye-Binding, Albumin |
| Regulation Section: | 21CFR862.1035, Albumin Test system |
| Classification: | Class II |
| Product Code: | CJW |
| Panel: | Clinical Chemistry |
| Classification Name: | Calibrator |
| Regulation Section: | 21CFR862.1150, Calibrator |
| Classification: | Class II |
| Product Code: | JIT |
| Panel: | Clinical Chemistry |
5
PREDICATE DEVICE
The following table describes the predicate devices, device classifications, regulations and product codes associated with this pre-market notification:
| New Product | Predicate Device | 510(k) number | Device Class | Regulation | Product Code |
|---|---|---|---|---|---|
| Trinidad CH System | Siemens ADVIA® 1800 Chemistry* | K990346 | I | 862.2160 | JJE |
| TD-LYTE Integrated Multisensor (Na, K, CI) | ADVIA® Sodium (Na) | ||||
| ADVIA® Potassium (K) | |||||
| ADVIA® Chloride (CI) | K990346 | II | (Na)862.1665 | ||
| (K)862.1600 | |||||
| (CI) 862.1170 | JGS | ||||
| CEM | |||||
| CGZ | |||||
| TD-LYTE IMT Standard A & TD-LYTE IMT Standard B + Salt Bridge | ADVIA® Chemistry ISE Serum Standard | ||||
| ADVIA® Chemistry ISE Urine Standard | K990346 | II | 862.1150 | JIX | |
| Trinidad CH Albumin BCP Reagent (Alb_P) | ADVIA® Chemistry Albumin BCP Assay (ALBP) | K132664 | II | 862.1035 | CJW |
| Trinidad CH Albumin BCP Calibrator | ADVIA® Chemistry Albumin BCP Calibrator | K132664 | II | 862.1150 | JIT |
*The ADVIA 1800 is a family member of the ADVIA 1650 cleared under K990346.
6
TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM
The Siemens Healthcare Diagnostics Trinidad CH System is a floor model, fully automated, microprocessor-controlled, integrated instrument system that uses prepackaged reagent packs to measure a variety of analytes in human body fluids. The system is a multi-functional analytical tool that processes chemical and immunochemical methodologies, utilizing photometric and integrated ion selective multisensor detection technologies for clinical use. The system includes the analytical module and the sample handler (Direct Load, DL).
TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)
Na, K, Cl uses indirect Integrated Multisensor Technology (IMT). There are four electrodes used to measure electrolytes. Three of these electrodes are ion selective for sodium, potassium and chloride. A reference electrode is also incorporated in the multisensor.
A diluted sample (1:10 with IMT Diluent) is positioned in the sensor and Na*, K* or Cl ions establish equilibrium with the electrode surface. A potential is generated proportional to the logarithm of the analyte activity in the sample. The electrical potential generated on a sample is compared to the electrical potential generated on a standard solution, and the concentration of the desired ions is calculated by use of the Nernst equation.
Serum, plasma and urine specimens may be used. The sensor is stored unopened at 2 – 8 °C and is stable for use on board for 14 days or 5000 samples.
TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE
The Trinidad CH System TD-LYTE Integrated Multisensor system performs a two point automatic calibration in duplicate every 4 hours. In addition, the system will routinely perform a one point calibration check with each sample measurement. Auto-calibration occurs after power-on, with the changing of standards A. B. or a sensor and when the system software is reset.
The target concentrations of the TD-LYTE IMT Standard A include: Nat at 14 mmol/L, K* at 0.4 mmol/L and Cl¯ at 10.4 mmol/L. The target concentrations of the TD-LYTE Standard B include: Na 7 mmol/L, K* at 6 mmol/L and Cli at 16 mmol/L. The target concentrations of the Salt Bridge include: K* at 120.0 mmol/L and Cl¯ at 120.3 mmol/L.
7
ALBUMIN BCP REAGENT
The Trinidad CH System Albumin BCP Reagent (Alb_P) assay is an adaptation of the bromocresol purple (BCP) dye-binding method reported by Carter and Louderback, et al. In the Trinidad CH System , the Alb_P assay, serum or plasma albumin quantitatively binds to BCP to form an albumin-BCP complex that is measured as an endpoint reaction at 596/694 nm.
Alb P is calibrated with Trinidad CH Diluent(11099300) and ALBP Calibrator (1 level). It is a 2-point linear curve.
Serum and plasma specimen types may be used. The reagent is stored at 2 - 8 °C and each well is stable on the sytem for 20 days.
ALBUMIN BCP CALIBRATOR
The Albumin BCP (Alb P) calibrator is a lyophilized human serum-based product containing albumin. It is used to calibrate the Albumin BCP (Alb_P) assay on the Trinidad CH System.
The target concentration of the albumin is 4.3 g/dL.
INTENDED USE
The Intended uses for the system and representative assays are described below.
TRINIDAD CLINICAL CHEMISTRY (CH) SYSTEM
The Trinidad CH System is an automated, clinical chemistry analyzer designed to perform in vitro diagnostic tests on clinical specimens. The system's chemical and immunochemical assay applications utilize photometric and ion selective electrode technology for clinical use.
TD-LYTE INTEGRATED MULTISENSOR (NA, K, CL)
For in vitro diagnostic use in the quantitative determination of sodium, potassium and chloride (Na, K, CI) in human serum, plasma and urine using the Trinidad CH System. Measurements of sodium obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Measurements of potassium obtained by this device are
8
used to monitor electrolyte balance in the diagnosis and treatment of disease conditions characterized by low or high blood potassium levels. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.
TD-LYTE IMT STANDARD A & TD-LYTE IMT STANDARD B + SALT BRIDGE
The TD-LYTE IMT Standard A is intended for the calibration of Na, K, and Cl on the Trinidad CH System.
The TD-LYTE IMT Standard B + Salt Bridge is intended for the calibration of Na. K, and Cl on the Trinidad CH System.
ALBUMIN BCP REAGENT
The Albumin BCP Reagent (Alb P) is intended for in vitro diagnostic use in the quantitative measurement of albumin in human serum or plasma on the Trinidad CH System. Albumin measurements are used in the diagnosis and treatment of numerous diseases primarily involving the liver or kidneys.
ALBUMIN BCP CALIBRATOR
The Albumin BCP calibrator is for in vitro diagnostic use in the calibration of the Trinidad CH Albumin BCP Assay (ALB_P) on the Trinidad CH System.
INDICATION(S) FOR USE
See Intended Use above.
SUBSTANTIAL EQUIVALENCE INFORMATION
Both the Trinidad CH system and the predicate ADVIA 1800 Chemistry system employ prepackaged reagents in plastic, Siemens Healthcare Diagnostics reagent packs. Both systems automatically process and analyze clinical samples using a variety of in vitro diagnostic test assays. Both systems utilize indirect potentiometric technology for analysis of sodium, potassium and chloride electrolytes. A comparison of the important similarities and differences of these two automated analyzer systems is provided in the following table:
Technological and Features Comparison of Trinidad CH System vs. ADVIA 1800 Chemistry System
9
| Feature | Predicate Device:
ADVIA 1800 Chemistry
System | New Device:
Trinidad CH System |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Fundamental | | |
| Type of System | Random continuous access,
batch, discrete processing | Same |
| Types of Measurements | Electrolyte, Photometric
and Turbidimetric | Electrolyte, Photometric |
| Optical system | Oil bath and cuvette optical
path length (10 mm) | Water bath and cuvette
optical path length
(7 mm) |
| Throughput Rate | 1800 tests/hour, 1200
tests/hour colorimetric, 600
tests/hour ISE | Same |
| Assay Capacity On-board | 56 slots including 3 ISE | Up to 70 slots including 3
ISE |
| Sample Handling | | |
| Sample Containers | Tubes - 5 mL, 7 mL, 10 mL
Cups - 2 mL sample cups | Same |
| Sample Type | Whole blood, serum,
plasma, CSF or urine | Same |
| Sample Tray | 84 samples, positive sample
identification | Samples identified and
delivered by Direct Load -
60 positions |
| Bar Codes | Interleaved 2 of 5, code 39,
code
128, Codabar (NW7) | Same with addition of
reagent pack data matrix 2D |
| Dedicated STAT
Positions | 84 positions/ Universal Rack
Handler available | All samples can be Stat
processed.
(Not dedicated) |
| Universal Rack Handler
(URH) Option | 5-position rack handler, 425
total
capacity, continuous feed | Samples delivered by
Direct load |
| Auto-repeat | Automatic repeat testing
from the retained pre-diluted
sample or original sample | Automatic repeat testing
from the retained pre-diluted
sample. |
| Auto-dilution | Automatic dilution from
retained pre-diluted sample | Same |
| Auto-reflex | Ability to perform 3 additional
tests based on results of first
test | Not available. |
| Liquid Level Sensing | Capacitance technology | Same |
| Automatic Sample Pre-
dilution | All samples diluted 1:5
(different
dilutions possible) | Same |
| Original sample volume | 2 to 30 µL; system uses an
average of 2-3 µL per test | 2 to 50 µL; system uses an
average of 2-3 uL per test. |
| Sample probes | Primary probe picks up
sample from primary tube or
cup, dispenses to
dilution tray;
secondary probe
dispenses saline into tray
to dilute sample – only
primary probe has clot
detect, crash protect & liquid
surface verification | Dilution probe picks up
primary sample from primary
tube or cup, and dispenses
to dilution tray with saline to
dilute sample.
A secondary probe
(Sample Probe) transfers an
aliquot of diluted sample to
reaction cuvette.
All probes have liquid
surface verification. |
| Pre-diluted Sample | Retained until results are
available | Same |
| Reaction Area | | |
| Reaction Tray | 221 reusable plastic cuvettes | Same |
| Cuvette Optical Path Length | 10 mm | 7 mm |
| Reaction Volume | 80-300 $µL$ | 80-240 $µL$ |
| Reaction Bath | Inert fluorocarbon oil
circulation system, 37°C | Water bath, 37°C |
| Photometer | 14 fixed wavelengths (12
utilized) | 11 fixed wavelengths |
| Turbidimetric Measurements | Made with photometer | Same |
| Light Source | 12V, 50W halogen lamp,
cooled by forced water
circulation | 12 V, 50 W Halogen lamp /
cooled by lamp coolant
additive and one LED |
| Assays | Endpoint, rate reaction, 2-
point rate. | Endpoint, rate reaction, 2-
point rate, sample blank
correction |
| Reaction Times | 3, 4, 5, 10, 15 and 21 minutes | 3 to 10 minutes |
| Reagent Handling | | |
| Reagent Tray | 2 refrigerated reagent trays,
56 positions each; 4 of these
positions may be occupied
by wash solutions and/or
diluents | 2 refrigerated reagent trays;
70 positions R1
70 Positions R2
Up to 4 of the positions of
R2 may be occupied by
wash solutions and/or
diluents. |
| Reagent cooling | 6-14° C | 4-12° C |
| Reagent Container | 20, 40, 70 mL wedges | Approximate maximum
wedge size of 50 mL. Packs
have two wells with 1 or 2
wells filled (depending on
assay) |
| Reagent Capacity On- board | 52 assay Reagents | Up to 70 Reagents
and 3 ISE |
| Dispensing System | 2 probes with liquid level
sensing | Same |
| Reagent Dispense volume | 10-100 µl per test | Same |
| Reagent Inventory
Management | Tracks tests remaining, lot
number, on-board stability
and expiration date | Same |
| Reagent Dilutions | Capability to dilute
concentrated reagents on-
board | Same |
| Electrolyte Measurement | | |
| Method Principle | Ion Selective Electrode | Same |
| ISE Internal Standard | None | Internal Standard |
| Sample Volume | 22 µL total for all three tests | 25 µL for all three tests |
| Throughput Rate | 600 tests/hour | Same |
| Calibration | | |
| Calibration Frequency | Up to 60 days | Up to 60 days |
| Auto-Calibration | User-defined time interval
or with new reagent cartridge | User-defined time interval or
with new reagent cartridge |
| Calibration/Control Tray | 61 refrigerated positions for
calibrators, controls and
diluents | Calibrators and controls
delivered by Direct Load /
manual input. |
| General Specifications | | |
| Power Requirements | 200/220/230 V +/-10%, 30
A, 50/60 Hz, 3 KVA | 200-240 VAC +/-10%, 8
Amp, 50/60 Hz, 3.2 KVA |
| Water Requirements | Direct plumb - Deionized
water Type I at the source
Type II at the system | Direct plumb - Lab Grade
Type 1 only |
| Water Consumption | 30 liters per hour | 33 liters per hour (maximum) |
| Dimensions | 113.3 (h) x 148.0 (w) x 87.7
(d) cm | Analytical Module:
1363.5 (h) x 1452.5 (w) x
1183.3 (d) mm
Direct Load:
1365 (h) x 425.3 (w) x 1150
(d) mm |
| Weight | 1,323 lbs. (540 kg) | CC Module:
962 lbs. (437 kg)
Direct Load
331 lbs. (150 kg) |
| Electrical Compliance | UL, cUL, CE | Same |
| Computers/OS | | |
| CPU | Single Intel Processor
running
Windows XP Pro | Intel processor using Windows
7 |
| Display/Monitor | 19" display (Touch screen
is optional) | 22" display with touch screen |
| Software | | |
| GUI Application | User interface unique to
ADVIA Chemistry systems | Universal Instrument
Workstation, which will be
common to new Siemens IVD
systems |
| Result Database
Capacity | 7 days of results
maintained in a flat file
system | Stores up to 1MM results. |
| On-Line Help | Separate for System
application
and ADVIA QC | Not available at this time |
| QC | ADVIA QC V3.2x
application
provides stored control
results, Levy-Jennings
plotting, and statistics | Same |
| LIS Interfaces | LIS ASTM standards
1394/1381,
and J-ASTM, LIS HL7
standards | Not available at this time |
| LAS Interfaces | Siemens URAP LAS
Interface | Utilize pick and place sampling
rather than point in space |
| Real-Time Solutions
(RTS) support | Interface to RTS via
LabCom protocol and RTS
via i2i protocol | Not available at this time |
| External printers | Parallel port and USB
interfaced printers | Not available at this time |
10
11
12
13
14
15
Below is a features comparison for the Trinidad CH system assays vs. their predicates:
| Feature | Predicate Device:
ADVIA 1800 Chemistry
System | New Device:
Trinidad CH System |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use :
Na, K, Cl | For in vitro diagnostic use in
the quantitative determination
of sodium in human serum,
plasma (lithium heparin), and
urine on the ADVIA
Chemistry systems.
For in vitro diagnostic use in
the quantitative determination
of potassium in human
serum, plasma (lithium
heparin), and urine on the
ADVIA Chemistry systems. | For in vitro diagnostic use
in the quantitative
determination of sodium,
potassium and chloride
(Na, K, Cl)
in human serum, plasma
and urine using the
Trinidad CH System. |
| | For in vitro diagnostic use in
the quantitative determination
of chloride in human serum,
plasma, and urine on the
ADVIA Chemistry systems. | |
| Albumin BCP | For in vitro diagnostic use in
the quantitative measurement
of albumin in human serum
or plasma on ADVIA®
Chemistry systems. | For in vitro diagnostic use
in the quantitative
measurement of albumin
in human serum or
plasma on Trinidad CH
System. |
| Indications for Use:
Na, K, Cl | Sodium measurements are
used in the diagnosis and
treatment of gross changes in
water and salt balance,
aldosteronism, diabetes
insipidus, adrenal
hypertension, Addison's
disease, dehydration,
inappropriate antidiuretic
hormone secretion, diabetic
acidosis, severe diarrhea, or
other diseases involving
electrolyte imbalance.
Potassium measurements
are used to monitor
electrolyte balance in the
diagnosis and treatment of
primary aldosteronism,
metabolic alkalosis, diarrhea,
severe vomiting, diuretic
administration, diabetic
ketoacidosis, and other
diseases.
Chloride measurements are
used for their inferential value
and are helpful in diagnosing
disorders of acid-base and
water balance. It is especially | Measurements of sodium
obtained by
this device are used in the
diagnosis and treatment
of aldosteronism
(excessive secretion of
the hormone
aldosterone), diabetes
insipidus (chronic
excretion of large
amounts of dilute urine,
accompanied by
extreme thirst), adrenal
hypertension, Addison's
disease (caused by
destruction of the adrenal
glands),
dehydration, inappropriate
antidiuretic hormone
secretion, or other
diseases involving
electrolyte
imbalance.
Measurements of
potassium obtained by
this device are used to
monitor electrolyte
balance in
the diagnosis and
treatment of disease
conditions characterized |
| | chloride during the correction
of hypokalemic alkalosis and
also during severe, prolonged
vomiting, which can lower the
serum chloride level. | by low or high blood
potassium levels.
Chloride measurements
are used in the diagnosis
and treatment of
electrolyte and metabolic
disorders
such as cystic fibrosis and
diabetic acidosis. |
| Albumin BCP | Albumin measurements are
used in the diagnosis and
treatment of numerous
diseases primarily involving
the liver or kidneys. | Albumin measurements
are used in the diagnosis and
treatment of
numerous diseases
primarily involving the
liver or kidneys. |
| Device Technology:
Na, K, CI | Indirect potentiometric
measurements with ion
selective electrodes | Indirect potentiometric
measurements with
Integrated Multisensor
Technology (IMT) |
| Albumin BCP | bromocresol purple (BCP)
dye-binding method | Same |
| Sample Type:
Na, K, CI | Serum/plasma/urine | Same |
| Albumin BCP | Serum/plasma | Same |
| Analytical Measuring
Interval:
Na, K, CI | Serum/Plasma
Na: 100 - 200 mmol/L
K: 1.0 - 10.0 mmol/L
Cl: 15 - 200 mmol/L
Urine
Na: 10 - 400 mmol/L
K: 3.0 – 300 mmol/L
Cl: 15 - 400 mmol/L | Serum/Plasma
Na: 50.0 to 200 mmol/L
K: 1.0 to 10.0 mmol/L
Cl: 50.0 to 200 mmol/L
Urine
Na: 10 to 300 mmol/L
K: 2 to 300 mmol/L
Cl: 20 to 330 mmol/L |
| Albumin BCP | ALBP 0.6-8.0 g/dL | Alb_P 0.5-8.0 g/dL |
| | | |
| Reference Interval:
Na, K, Cl | Serum/Plasma
Na: 132 – 146 mmol/L
K (Serum): 3.5 – 5.5 mmol/L
K (Plasma/males): 3.5 – 4.5
mmol/L
K (Plasma/females): 3.4 – 4.4
mmol/L
Cl: 99 – 109 mmol/L | Serum/Plasma
Na: 136–145 mmol/L
K (serum): 3.5–5.1
mmol/L
K (plasma): 3.4-4.5
mmol/L
Cl: 98–107 mmol/L |
| | Urine
Na: 40 – 220 mmol/day
K: 25 – 125 mmol/day
Cl: 110 - 250 mmol/day | Urine
Same |
| Albumin BCP | ALBP: 3.4-5.0 g/dL | Alb_P Same |
| Interferences:
Na, K, Cl | Na: Bilirubin (Conjugated) –
25 mg/dL
Bilirubin (Unconjugated) – 25
mg/dL
Lipemia – 500 mg/dL
Hemoglobin - 500 mg/dL | Na: Bilirubin
(Conjugated) – 60 mg/dL
Bilirubin (Unconjugated) –
60 mg/dL
Lipemia (Intralipid®) –
3000 mg/dL
Hemoglobin - 750 mg/dL |
| | K:Bilirubin (Conjugated) – 25
mg/dL
Bilirubin (Unconjugated) – 25
mg/dL
Lipemia - 500 mg/dL | K: Bilirubin (Conjugated) –
60 mg/dL
Bilirubin (Unconjugated) –
60 mg/dL
Lipemia (Intralipid®) –
3000 mg/dL |
| | Cl:Bilirubin (Conjugated) – 25
mg/dL
Bilirubin (Unconjugated) – 25
mg/dL
Lipemia – 500 mg/dL
Hemoglobin - 500 mg/dL | Cl: Bilirubin (Conjugated)
– 60 mg/dL
Bilirubin (Unconjugated) –
60 mg/dL
Lipemia (Intralipid®) –
3000 mg/dL
Hemoglobin - 750 mg/dL |
| Albumin BCP | ALBP: Bilirubin (Conjugated)
– 60 mg/dL | Alb_P Bilirubin
(Conjugated) – 30 mg/dL |
| | Bilirubin (Unconjugated) - 60 mg/dL | Bilirubin (Unconjugated) - 30 mg/dL |
| | Lipemia - 500 mg/dL
Hemoglobin - 500 mg/dL | Lipemia – 500 mg/dL
Hemoglobin – 600 mg/dL |
| Standardization: | | |
| Na, K, CI | NA: Flame photometric
method with NIST reference
standards
K: Flame photometric method
with NIST reference serum
Cl: Coulometric method with
NIST standards | Same |
| Albumin BCP | ALBP: ERM-DA470k
Reference Material | Same |
| Calibration Frequency: | | |
| Na, K, CI | Daily | Every 4 hours |
| Albumin BCP | Every 60 days | Every 30 days |
| Calibrators: | | |
| Na, K, CI | ADVIA Chemistry ISE Serum
Standard & ADVIA Chemistry
ISE Urine Standard Set | TD-LYTE IMT Standard A
and TD-LYTE IMT
Standard B + Salt Bridge |
| Albumin BCP | ADVIA Chemistry Albumin
BCP Calibrator | Albumin BCP Calibrator |
| Calibrator Matrix: | | |
| Na, K, CI | Na/K/CI: Buffered Aqueous
matrix | Same |
| Albumin BCP | ALBP: Human Serum | Same |
| Calibrator Form:
Na, K, CI | Na/K/CI: liquid | Same |
| Albumin BCP | ALBP: Lyophilized | Same |
| Number of Calibrator
Levels: | | |
| Na, K, CI | Na/K/CI: Two for serum
and Two for Urine | Two for serum/urine |
| Albumin BCP | ALBP: One | Same |
16
17
18
19
20
ASSAY PERFORMANCE CHARACTERISTICS
Assay performance comparison results for the representative Trinidad CH system assays and their predicate assays were obtained by processing the appropriate body fluids. Summary statistics for each representative assay are provided. These data demonstrate substantial equivalency of the representative assays processed on the Trinidad CH system versus their predicate assays. The following data represent typical assay performance.
DETECTION LIMIT
The Limit of Blank (LoB) and Limit of Detection (LoD) were evaluated in accordance with CLSI EP17-A2 Protocols for Determination of Limits of Detection and Limits of Quantitation: Approved Guideline.
| TD-LYTE Integrated Multisensor (Na, K, Cl)
| Limit of Detection Results with Serum | ||
|---|---|---|
| Limit | Protocol | Result |
| LoB | 4 samples with no analyte | |
| were tested (N=5) for 3 | ||
| days, one run per day, 2 | ||
| reagent lots, | Na: 10.2 mmol/L | |
| K: 0.244 mmol/L | ||
| Cl: 2.23 mmol/L | ||
| LoD | 4 low or diluted patient | |
| serum samples were | ||
| tested (N=5) for 3 days, | ||
| one run per day, 2 reagent | ||
| lots | Na: 11.9 mmol/L | |
| K: 0.279 mmol/L | ||
| Cl: 4.43 mmol/L | ||
| TD-LYTE Integrated Multisensor (Na, K, Cl) | ||
| Trinidad CH Limit of Detection Results with Urine | ||
| Limit | Protocol | Result |
SODIUM, POTASSIUM, CHLORIDE
21
| LoB | 4 samples with no analyte
were tested (N=5) for 3
days, one run per day, 2
reagent lots, | Na: 4.72 mmol/L
K: 0.00 mmol/L
Cl: 4.86 mmol/L |
|-----|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| LoD | 4 low or diluted patient
urine samples were tested
(N=5) for 3 days, one run
per day, 2 reagent lots | Na: 5.30 mmol/L
K: 0.079 mmol/L
Cl: 5.47 mmol/L |
The nonparametric approach described in EP-17A2 was followed to determine the Limit of Detection.
ALBUMIN
LoB and LoD were determined as described in CLSI Document EP17-A2. Six blank samples composed saline diluent and water were processed with three reagent lots for three days, on one instrument for a total of 90 measurements per reagent lot. Five low samples composed of diluted serum were processed on three reagent lots for three days, on one instrument for a total of 75 measurements per lot. LoB: used nonparametric approach. LoB = 95th percentile of all values LoB studies were completed with 3 reagent lots.
| Trinidad CH Albumin_P
| Limit of Detection Results | ||
|---|---|---|
| Limit | Protocol | Result |
| LoB | 6 samples with no analyte | |
| were tested (N=5) for 3 days, | ||
| one run per day, 3 reagent lots | 0.1 g/dL | |
| LoD | 5 low and diluted patient | |
| serum samples were tested | ||
| (N=5) for 3 days, one run per | ||
| day, 3 reagent lots | 0.2 g/dL |
SODIUM, POTASSIUM, CHLORIDE_LOQ
The Limit of Quantitation (LoQ) for serum and urine fluids were determined as described in CLSI Document EP17-A2 for Na, K and Cl. Total Error is calculated using: TE = bias + 2 * SD. The reference values are traceable to the reference standard. For both serum and urine, four low samples composed of diluted samples (serum or urine), were processed on two IMT sensor lots for three days, on one instrument for a total of 60
22
measurements per lot. The average, SD, and bias relative to the reference values were calculated for each sample per reagent lot. These values were used to calculate the TE per the Westgard model for each sample.
The LoQ for Na for serum and plasma is 40.4 mmol/L [40.4 mEq/L]. based on 120 determinations: and observed total error of 4.8% calculated using the Westgard model. The LoQ for Na for urine is 5.35 mmol/L [5.35 mEq/L], based on 120 determinations; and observed total error of 1.78 mmol/L [1.78 mEq/L] or 27% calculated using the Westgard model.
The LoQ for K for serum and plasma is 0.792 mmol/L [0.792 mEq/L], based on 120 determinations; and observed total error of 16.3% calculated using the Westgard model. The LoQ for K for urine is 1.03 mmol/L [1.03 mEg/L], based on 120 determinations; and observed total error of 22% calculated using the Westgard model.
The LoQ for Cl for serum and plasma is 38.3 mmol/L [38.3 mEq/L], based on 120 determinations; and observed total error of 10.3% calculated using the Westgard model. The LoQ for Cl for urine is 15.8 mmol/L [15.8 mEq/L], based on 120 determinations; and observed total error of 16% calculated using the Westgard model.
ALBUMIN LOQ
Five low samples composed of diluted serum pools were processed on three reagent lots for three days, on one instrument for a total of 75 measurements per reagent lot. The lowest sample concentration that met the LoQ inter-assay precision acceptance criteria is 0.41 g/dL. Limit of Quantitation (LoQ) is 0.4 g/dL (4 g/L) based on 225 determinations, with an inter-assay precision of